Because You Asked: Research Results

The ASTRO annual meeting was held last month in San Antonio, and ASH 2022 is next month in New Orleans – its abstracts were released on the meeting website just yesterday. We’ve got great work representing SWOG at both of these meetings, including the following:

• SWOG’s S1007 RxPONDER trial enrolled more than 5,000 women with HR+, HER2- breast cancer who had one to three involved lymph nodes and a 21-gene recurrence score (RS) of 25 or less. Primary results were reported in the New England Journal of Medicine last year. 
  At the recent ASTRO meeting, SWOG investigator Reshma Jagsi, MD, DPhil, of the University of Michigan Rogel Cancer Center, presented an analysis of the use of radiation therapy in treating these patients. Jagsi’s team primarily wanted to know whether women with a low RS – and hence at lower risk – needed regional node irradiation to reduce their risk of locoregional recurrence of the disease. They found that data from RxPONDER did not give a clear indication, suggesting that only a randomized clinical trial dedicated specifically to this question could provide a definitive answer. Fortunately, such a study is currently underway, the TAILOR RT trial (NCIC MA-39) being led by the Canadian Cancer Trials Group, with NCI co-sponsorship.
   
• Also presented at ASTRO 2022 were interim toxicity data from the S/N1806 study, which showed nosignificant safety concerns with the investigative arm’s combination therapy. Run jointly by SWOG and NRG Oncology, the study tests a chemoradiation/ immunotherapy combo in treating localized muscle-invasive bladder cancer. Parminder Singh, MD, of the Mayo Clinic Arizona, was lead author on the toxicity analysis, which was presented at ASTRO by Sameer G. Jhavar, MD, PhD, of Baylor Scott and White Health. S/N1806 is North America’s largest cancer trial investigating bladder-preserving therapy.
   
• As SWOG biostatistician Anna Moseley, MS, and her colleagues were designing protocols in acute myeloid leukemia that would fit under the MyeloMATCH umbrella trial, they looked for published data that would help them advise study teams on just how many stratification factors they could use in a smallish phase 2 trial without reducing the trial’s statistical power. These data were nowhere to be found, so they set out to generate such data themselves. 
  Moseley led a team that simulated many iterations of trial data based on the design of a MyeloMATCH subprotocol they were working on. They found that for trials of this size (84 participants, in this case), stratified analysis with more than just one or two stratification factors could significantly reduce the trial’s power to detect a positive result. The findings, which Moseley will present at ASH next month, can help statisticians give study teams more informed advice about limiting the number of stratification factors when designing a trial.
   
• The final abstract I want to report on is a trials-in-progress (TIPS) abstract for ASH – not typically something that makes headlines. In this case, however, the trial almost in progress is MyeloMATCH, the precision medicine umbrella trial in myeloid malignancies. SWOG is leading the MyeloMATCH screening protocol, and Rich Little, MD, MPH, of the National Cancer Institute, will present a poster on the trial’s overall structure. One line from this abstract sums up just what makes MyeloMATCH unique even among the NCI’s growing portfolio of umbrella trials: “MyeloMATCH is the largest focused investment of infrastructure and researchers ever coordinated by the US Network Groups and NCI that follows patients from diagnosis through all treatment in a single disease area” (italics mine).

I suppose this last bullet may not technically qualify as a research result (presult?), but I’m confident the trial-in-progress it describes will spawn many, many future research results worthy of reporting in a venue such as this.